Evidence map›Paper›PMID 42592300›Full record

ArticleActa pharmaceutica Sinica. B2026

Design, preclinical evaluation, and multicenter phase 1 clinical study of HZ-A-018 for relapsed or refractory central nervous system lymphoma.

Shenglan Li, Jialiang Lu, Zhuang Kang, Haiyan Yang, Wenbin Qian, Xi Chen, Xianggui Yuan, Miao Hu, Qiuqiu Shi, Xinglu Zhou and 3 more

Abstract read
In one paragraph

Article in Acta pharmaceutica Sinica. B, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Shenglan LiCancer Center, Beijing Tiantan Hospital, Capital Medical University, Beijing 100070, China.
Jialiang LuCollege of Pharmaceutical Sciences, Zhejiang University, Hangzhou 310058, China.
Zhuang KangCancer Center, Beijing Tiantan Hospital, Capital Medical University, Beijing 100070, China.
Haiyan YangDepartment of Lymphoma, Zhejiang Cancer Hospital, Hangzhou 310022, China.
Wenbin QianDepartment of Hematology, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310009, China.
Xi ChenDepartment of Lymphoma, Zhejiang Cancer Hospital, Hangzhou 310022, China.
Xianggui YuanDepartment of Hematology, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310009, China.
Miao HuHealZen Therapeutics Co., Ltd., Hangzhou 310018, China.
Qiuqiu ShiCollege of Pharmaceutical Sciences, Zhejiang University, Hangzhou 310058, China.
Xinglu ZhouHealZen Therapeutics Co., Ltd., Hangzhou 310018, China.
Feng ChenCancer Center, Beijing Tiantan Hospital, Capital Medical University, Beijing 100070, China.
Xiaowu DongCollege of Pharmaceutical Sciences, Zhejiang University, Hangzhou 310058, China.
Wenbin LiCancer Center, Beijing Tiantan Hospital, Capital Medical University, Beijing 100070, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Effective therapy for relapsed or refractory central nervous system lymphoma (r/r CNSL) remains an unmet medical need. Meanwhile, developing antitumor drugs for CNS malignancies faces the dual challenge of achieving effective blood‒brain barrier (BBB) penetration and potent tumor cell killing. To address these challenges, a comprehensive predictive system was established to support decision-making during the discovery of HZ-A-018, a potent and BBB-permeable Bruton tyrosine kinase (BTK) inhibitor. This study further presents key preclinical results for HZ-A-018, as well as efficacy/safety data from a multicenter Phase 1 trial in r/r CNSL patients. HZ-A-018 demonstrated manageable safety, with only 19.2% of patients experienced grade 3 or higher adverse events according to the Common Terminology Criteria for Adverse Events version 5.0. Treatment with HZ-A-018 at the recommended phase II dose (RP2D) of 600 mg achieved an overall response rate (ORR) of 72.7% (95% CI, 39.0-94.0) and a 12-month survival rate of 90.5%. The Center for Drug Evaluation in China has authorized the initiation of this single-arm Phase II study as a pivotal registrational clinical trial for accelerated approval of HZ-A-018 for monotherapy in patients with r/r PCNSL. This trial has been registered under the identifiers ChiCTR2400091821 at www.chictr.org.cn and CTR20210181 at www.chinadrugtrials.org.cn.

Indexed as

AI-driven drug discoveryBBB permeabilityBlood‒brain barrierBruton tyrosine kinaseBTK inhibitorsCentral nervous system lymphomaHZ-A-018Phase 1 clinical trial

Identifiers

PMID42592300
PMCPMC13464085

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.